(102 days)
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time. It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.
Here's a breakdown of the acceptance criteria and study details for the ConTIPI Ltd. vaginal pessary device, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Objective Efficacy: ≥ 70% reduction in pad weight | 94% of participants achieved > 70% reduction (p80% reduction. |
| Subjective Efficacy: Participant's perception of being dry | 92% considered themselves dry compared to the first week and last few days of use. |
| Subjective Efficacy: Leak Score Quality of Life (QoL) questionnaire reduction | Total score decreased from 21.26 (pre-trial) to 5.3 (post-trial). |
| Safety: Adverse events | 6.6% reported adverse events, which is lower than other predicate study results. |
| Biocompatibility | Demonstrated per ISO 10993-1. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Fifty (50) participants.
- Data Provenance: Not explicitly stated, but the company is based in Haifa, Israel, suggesting the study likely took place in Israel. The data is prospective, as it involved actively recruiting and following participants.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the summary. The study collected objective (pad weight) and subjective (participant perception, QoL questionnaire) endpoints directly from participants, rather than relying on expert interpretation of data like images or clinical signs.
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Adjudication Method for the Test Set:
- None specified. For objective measures like pad weight, adjudication typically isn't required. For subjective measures, participant reporting serves as the "ground truth."
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (MRMC) is typically conducted for diagnostic imaging devices where different readers interpret the same cases. This device is a therapeutic device, and the study focused on its direct impact on patient symptoms and quality of life.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- Yes, effectively. This device is a standalone therapeutic product; it does not involve an algorithm, nor does it require human-in-the-loop interaction in the context of an AI-driven system. The "performance" measured is the direct effect of the device on the user.
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Type of Ground Truth Used:
- Objective measurements (pad weight) and Subjective patient-reported outcomes (perception of dryness, Quality of Life questionnaire).
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Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The 50-participant study served as the primary clinical validation for regulatory submission.
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How the Ground Truth for the Training Set was Established:
- Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this device.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).